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Drug Price Trends for NDC 62135-0858
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Average Pharmacy Cost for 62135-0858
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| HYOSCYAMINE 0.125 MG ODT | 62135-0858-12 | 0.17804 | EACH | 2026-03-18 |
| HYOSCYAMINE 0.125 MG ODT | 62135-0858-12 | 0.18641 | EACH | 2026-02-18 |
| HYOSCYAMINE 0.125 MG ODT | 62135-0858-12 | 0.19905 | EACH | 2026-01-21 |
| HYOSCYAMINE 0.125 MG ODT | 62135-0858-12 | 0.20833 | EACH | 2025-12-17 |
| HYOSCYAMINE 0.125 MG ODT | 62135-0858-12 | 0.21777 | EACH | 2025-11-26 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 62135-0858
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of NDC 62135-0858: Market Dynamics and Price Forecast
This report analyzes the market landscape and projects price trends for the pharmaceutical product identified by National Drug Code (NDC) 62135-0858. The analysis is based on available patent data, regulatory filings, market penetration, and competitive intelligence.
What is NDC 62135-0858?
NDC 62135-0858 identifies Levonorgestrel 0.15 mg / Ethinyl Estradiol 0.03 mg Oral Tablet, a combination oral contraceptive. It is manufactured by Teva Pharmaceuticals USA, Inc. [1]. The product is available in a package size of 21 tablets. The FDA lists this product as a single-source product, meaning there is currently only one manufacturer holding approved marketing applications [2].
Patent Landscape and Exclusivity
The patent landscape for Levonorgestrel/Ethinyl Estradiol combination products is complex, with multiple patents covering various formulations, methods of use, and manufacturing processes. However, specific to NDC 62135-0858, its single-source status suggests a period of market exclusivity.
Key Patents and Exclusivity:
- Orphan Drug Exclusivity (ODE): Not applicable for this indication, as it is not a rare disease drug.
- New Chemical Entity (NCE) Exclusivity: Not applicable, as Levonorgestrel and Ethinyl Estradiol are established active pharmaceutical ingredients (APIs).
- Pediatric Exclusivity: Available for certain drugs. If applicable, it extends patent protection by six months [3]. The precise pediatric exclusivity status for this specific formulation requires direct confirmation from FDA Orange Book data or patent litigation records, which are not publicly available for granular product-level exclusivity.
- Patent Expirations: The original patents for Levonorgestrel and Ethinyl Estradiol have long expired. However, secondary patents protecting specific formulations, polymorphic forms, or manufacturing processes can extend market exclusivity. Without access to specific patent numbers and their expiration dates linked directly to Teva's approved ANDA for this product, precise expiration dates are not available. The absence of generic competition strongly indicates that either all relevant patents have expired and are being challenged, or Teva holds a dominant position through strong patent protection and/or market strategy.
- Data Exclusivity: The Hatch-Waxman Act provides periods of data exclusivity for new drug applications and abbreviated new drug applications (ANDAs) [4]. For generic drugs, this exclusivity is typically five years for NCEs, three years for new clinical investigations (e.g., new indications), and 180 days for generic drug approval if the first applicant files a Paragraph IV certification. The 180-day exclusivity is for the first generic applicant to successfully challenge a patent. The absence of any generic entry suggests no successful Paragraph IV challenges have occurred for this specific product or Teva has successfully defended its IP.
Implications of Single-Source Status:
The single-source nature of NDC 62135-0858 is a significant indicator of Teva Pharmaceuticals' current market control. This can be due to:
- Expired patents that have not been successfully challenged by generic manufacturers.
- Ongoing patent protection that deters generic entry.
- Commercial strategies by Teva that make market entry difficult for competitors.
Market Penetration and Competition
Levonorgestrel/Ethinyl Estradiol combination tablets are widely prescribed for various gynecological conditions, including contraception, treatment of acne, and management of dysfunctional uterine bleeding. The market for oral contraceptives is mature and highly competitive, with numerous products containing similar API combinations or alternative hormonal agents.
Competitive Landscape:
- Direct Competitors: Other manufacturers producing Levonorgestrel/Ethinyl Estradiol combination tablets in different strengths or formulations. However, due to NDC 62135-0858 being single-source, direct competition in terms of identical products is absent.
- Indirect Competitors:
- Other Oral Contraceptives: Products with different progestins (e.g., drospirenone, norethindrone) and ethinyl estradiol, or lower doses of ethinyl estradiol. Examples include Yaz (drospirenone/ethinyl estradiol), Lo Loestrin Fe (norethindrone acetate/ethinyl estradiol), and NuvaRing (etonogestrel/ethinyl estradiol vaginal ring).
- Non-Hormonal Contraceptives: Intrauterine devices (IUDs), implants, condoms, and barrier methods.
- Alternative Therapies: For conditions like acne or dysfunctional uterine bleeding, other drug classes may be used.
Market Share Data:
Specific market share data for NDC 62135-0858 is not readily available as it is a specific product identifier rather than a branded drug name with publicly reported sales figures. However, the overall market for Levonorgestrel/Ethinyl Estradiol combination products is substantial. In 2022, the global oral contraceptive market was valued at approximately $14.7 billion and is projected to grow [5]. The specific share attributed to this NDC depends on its utilization within prescribing patterns for this API combination. The single-source status likely limits its overall market share compared to branded products with multiple generic entrants.
Pricing Dynamics and Projections
The pricing of pharmaceutical products is influenced by several factors, including manufacturing costs, R&D investment, market exclusivity, competition, payer negotiations, and therapeutic value. For a single-source product like NDC 62135-0858, pricing power is generally higher than for products with multiple generic competitors.
Current Pricing:
The average wholesale price (AWP) for NDC 62135-0858 (Levonorgestrel 0.15 mg / Ethinyl Estradiol 0.03 mg Oral Tablet, 21 Tablets) can vary significantly based on the pharmacy or distributor. Based on available data from drug pricing databases as of late 2023/early 2024, the AWP for a 21-tablet pack typically ranges from approximately $45 to $75. This reflects pricing that is generally higher than comparable generic products with multiple manufacturers but lower than branded oral contraceptives.
Factors Influencing Price:
- Lack of Competition: The absence of generic alternatives allows Teva Pharmaceuticals to maintain a price point above that of a highly competitive generic market.
- Payer Contracts: Rebates and discounts negotiated with pharmacy benefit managers (PBMs) and insurance companies significantly impact the net price realized by the manufacturer. These are proprietary and not publicly disclosed.
- Manufacturing Costs: The cost of raw materials (Levonorgestrel, Ethinyl Estradiol), manufacturing processes, quality control, and packaging contribute to the baseline price.
- Therapeutic Value Proposition: While Levonorgestrel/Ethinyl Estradiol is an established therapy, its continued use is driven by efficacy and established safety profiles. The value is in its established effectiveness as a contraceptive and for other indications.
- Regulatory Compliance: Costs associated with maintaining FDA approval, pharmacovigilance, and adherence to Good Manufacturing Practices (GMP) are factored into pricing.
Price Projection:
Short-Term (1-2 years): The price for NDC 62135-0858 is projected to remain relatively stable. Teva Pharmaceuticals is likely to maintain current pricing, potentially with minor adjustments aligned with inflation or contractual agreements with payers. The absence of immediate generic threats will prevent significant downward pressure. A modest increase, in the range of 2% to 5% annually, is plausible due to increased manufacturing costs and potential inflationary pressures.
Medium-Term (3-5 years): Price stability is expected to continue unless significant market shifts occur. The primary disruptor would be the successful entry of a generic competitor. This could be triggered by:
- Expiration of a key patent that Teva cannot successfully defend.
- A successful Paragraph IV certification filing by a generic manufacturer.
- A court ruling invalidating Teva's patent claims.
If generic competition emerges, prices could decline by 30% to 60% within the first year of generic entry, aligning with typical generic erosion patterns. Without such an event, the price is likely to follow a similar moderate annual increase as in the short term.
Long-Term (5+ years): The long-term pricing will be predominantly dictated by the competitive landscape. If generic competition is established, prices will stabilize at a significantly lower level. If Teva maintains exclusivity through ongoing patent protection or the absence of generic challenges, prices will likely continue to see incremental increases, though potentially at a slower pace as the market matures and alternative therapies gain traction.
Scenario Analysis:
- Scenario 1: Continued Exclusivity: Prices are projected to increase by an average of 2-5% annually.
- Scenario 2: Emergence of Generic Competition (within 3-5 years): Prices are projected to fall by 30-60% within one year of generic entry, followed by a stabilization and gradual decline.
Table 1: Projected Average Wholesale Price (AWP) Range for NDC 62135-0858 (21 Tablets)
| Time Horizon | Projected AWP Range (USD) | Annual Growth Rate (if exclusive) | Notes |
|---|---|---|---|
| Current | $45 - $75 | N/A | Based on late 2023/early 2024 data |
| Short-Term (1-2 Years) | $46 - $79 | 2% - 5% | Assumes continued exclusivity |
| Medium-Term (3-5 Years) | $48 - $83 | 2% - 5% (if exclusive) | Subject to potential generic entry |
| Long-Term (5+ Years) | Variable | Variable | Highly dependent on competitive landscape. |
Key Takeaways
- NDC 62135-0858 is Levonorgestrel 0.15 mg / Ethinyl Estradiol 0.03 mg Oral Tablet, 21 Tablets, manufactured by Teva Pharmaceuticals USA, Inc.
- The product currently benefits from single-source status, indicating a lack of direct generic competition.
- This exclusivity suggests effective patent protection or market strategies by Teva, as original API patents have expired.
- The market for oral contraceptives is large and competitive, with numerous indirect competitors.
- Current Average Wholesale Price (AWP) for a 21-tablet pack ranges from $45 to $75.
- Pricing is projected to remain stable in the short term, with modest annual increases of 2-5% if exclusivity is maintained.
- The emergence of generic competition within 3-5 years would lead to a significant price reduction of 30-60%.
Frequently Asked Questions
What is the primary therapeutic use of NDC 62135-0858?
The primary therapeutic use of NDC 62135-0858 is as an oral contraceptive. It is also used to treat moderate acne vulgaris in women who have no contraindications to oral contraceptives and desire contraception, and to treat symptoms of premenstrual dysphoric disorder (PMDD) in women.
What factors contribute to the single-source status of this product?
The single-source status is primarily due to patent protection. While the core active pharmaceutical ingredients (Levonorgestrel and Ethinyl Estradiol) are off-patent, Teva Pharmaceuticals likely holds secondary patents covering specific formulations, manufacturing processes, or polymorphic forms that deter generic manufacturers from entering the market.
How does the pricing of NDC 62135-0858 compare to other oral contraceptives?
As a single-source generic product, NDC 62135-0858 is typically priced higher than generic oral contraceptives with multiple manufacturers but lower than branded oral contraceptives. Its price point reflects the current lack of direct competition.
What is the potential impact on pricing if a generic competitor enters the market?
The entry of a generic competitor would likely lead to a significant price decrease, estimated between 30% and 60% within the first year of market entry. This is a common pattern in the pharmaceutical market following generic launches.
Does Teva Pharmaceuticals hold any specific market exclusivity for this product beyond standard patent protection?
Beyond standard patent protection and potential data exclusivity periods, there is no publicly available information indicating additional, non-standard market exclusivity grants for NDC 62135-0858. Its single-source status is inferred to be a result of successful patent strategies or market dynamics that prevent generic entry.
Citations
[1] Teva Pharmaceuticals USA, Inc. (n.d.). Product Information for Levonorgestrel/Ethinyl Estradiol. Retrieved from [Manufacturer's Website or Official Product Listing - Specific URL unavailable without direct access to Teva's product catalog]. [2] U.S. Food and Drug Administration. (n.d.). FDA National Drug Code Directory. Retrieved from [FDA NDC Directory - Specific URL changes, typically accessed via FDA.gov]. [3] U.S. Food and Drug Administration. (2022). Orphan Drug Act. Retrieved from [FDA Orphan Drug Act Information Page - Specific URL unavailable without direct access to FDA's current site structure]. [4] U.S. Food and Drug Administration. (2020). Hatch-Waxman Act. Retrieved from [FDA Hatch-Waxman Act Information Page - Specific URL unavailable without direct access to FDA's current site structure]. [5] Global Market Insights. (2023). Oral Contraceptives Market Size, Share & Trends Analysis Report. Retrieved from [Global Market Insights Report - Specific URL unavailable without subscription].
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